NCT04461366

Brief Summary

Background: The acne scar is a common disorder characterized by skin eruption or abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic appearance. Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF) or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the form of reducing acne scars and improving the cosmetic appearance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

July 2, 2020

Last Update Submit

July 7, 2020

Conditions

Acne Atrophica

Keywords

Acne scarsMonopolar radiofrequencyPulsed dye laser

Outcome Measures

Primary Outcomes (2)

  • acne scars severity by investigator

    Clinical evaluation scale for acne scarring. Using this scale, the type of scar was defined by the qualitative descriptions of scars, which is then accompanied by a numerical score (0-4) and then multiplied by (15-50) which is a weighting factor of clinical severity, the total possible score is from 0 to 540. Higher score means worse outcome while lower score means better out come.

    after 8 weeks of intervention

  • acne scars severity by the participant

    Self-assessment of clinical acne-related scars questionnaire. It consists of 5-items with 1 hypothesized domain which asks patients to assess acne scars severity as seen in the mirror. The total possible score is from 0- 20. Higher score means worse outcome while lower score means better out come.

    after 8 weeks of intervention

Secondary Outcomes (1)

  • emotional, social functioning and work/school effect of scars

    after 8 weeks of intervention

Study Arms (2)

monopolar radiofrequency (MRF) group

EXPERIMENTAL

Monopolar Radiofrequency Diathermy (LVT-250, Korea) was used at average energy160-180 W, main power 50/60 Hz, 40˚C \~ 45˚C Temperature, RF output 470 kHz, 20 mm electrode size.

Device: Monopolar radiofrequency

Pulsed dye laser (PDL) group

ACTIVE COMPARATOR

Flash lamp pulsed dye laser; Candela SPTL-1 (Candela Corp., Wayland, Mass.) with the following parameters: (585nm wavelength, 450 msec pulse duration, 6.5 to 7.5 J/cm² energy density and 5or 7mm spot size).

Device: Pulsed dye laser

Interventions

Monopolar radiofrequencyDEVICE

The RF electrode was moved randomly for 30 seconds over each scar. The total duration of the treatment session is only 5 minutes for each cheek. It takes 15 minutes if the forehead and 2 cheeks are affected.

monopolar radiofrequency (MRF) group
Pulsed dye laserDEVICE

PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.

Pulsed dye laser (PDL) group

Eligibility Criteria

Age19 Years - 23 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadolescents
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with mild to severe acne scar
  • Patients with acne scar in the face

You may not qualify if:

  • Smokers and alcohol drinker
  • Patients who had a history of diabetes, circulatory or sensory disorders
  • Patients who had a history of frequent sunburns
  • Patients with nodulocystic acne

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radwa T Elshorbagy

Giza, 12111, Egypt

Location

MeSH Terms

Interventions

Lasers, Dye

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Nesma M Allam, PhD

    lecturer at faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

January 15, 2019

Primary Completion

December 30, 2019

Study Completion

July 1, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

I will share data 6 months after publication

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
study protocol

Locations

EG(1)